Active — Not RecruitingEarly Phase 1

Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

Greece80 participantsStarted 2021-09-24

Plain-language summary

Investigation of the combination of neonatal neurobehaviourism and motor behavior in the assessment and ultra-early physical therapy intervention of premature neonates and parental support.

Who can participate

Age range3 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Gestational age under 37 weeks * Premature newborns hospitalised in the NICU for at least eight days * (for parents) be able to speak and read Greek or English Exclusion Criteria: * Newborns with congenital and chromosomal abnormalities. * Newborns with severe accompanying pathological problems and congenital infections. * (for parents) with known history of drug or alcohol abuse or serious psychiatric disorders

What they're measuring

The neonatal behavioural assessment scale (NBAS)

Timeframe: newborn - 2 month old (corrected age)

The New-born Behavioral Observations (NBO)

Timeframe: Βirth through the 3rd month of life

The Qualitative Assessment of General Movements (GMsA)

Timeframe: birth to 20 weeks (corrected age)

• Karitane Parenting Confidence Scale (KPCS) (Crncec, R., et all., 2008, 2010)

Timeframe: Birth to 12 months

• Parental Stressor Scale: Neonatal Intensive Care Unit (Pss: Nicu) (Miles, M. S., Funk, S. G., & Carlson, J., 1993)

Timeframe: From Enrollment to the end of interventional 3 months

Trial details

NCT IDNCT05565287

SponsorUniversity of Thessaly

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Neonatal Disease trials